Yonette Thomas, of Howard University, introduced the final session of the workshop that provided a look at the role of institutional review boards (IRBs) from three very different perspectives, that of a university official overseeing human research participants protection, a sociocultural anthropologist who must deal with IRBs in her work, and a research funder.

Lois Brako, of the University of Michigan, Ann Arbor, offered some observations and suggestions about the proposed changes to the Common Rule, based on her experiences with regulatory and compliance oversight at the University of Michigan. She described the university’s human research protections program as one that seeks to maximize its opportunities to be flexible and innovative, and noted ways the university works to take full advantage of the flexibility in the regulations concerning human subjects protection. The university limits the scope of the federalwide assurance by applying it only to federally funded projects. “It’s really important on a campus like ours with so many student projects,” she said. “This allows us to do some local review if we want….Again, our school has tried to take full advantage of this,” she noted.

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Session 6
Purview and Roles of
Institutional Review Boards
Y
onette Thomas, of Howard University, introduced the final session
of the workshop that provided a look at the role of institutional
review boards (IRBs) from three very different perspectives, that of
a university official overseeing human research participants protection, a
sociocultural anthropologist who must deal with IRBs in her work, and
a research funder.
PERSPECTIVE OF A HUMAN RESEARCH PROTECTIONS
PROGRAM THAT MAXIMIZES OPPORTUNITIES
TO BE FLEXIBLE AND INNOVATIVE
Lois Brako, of the University of Michigan, Ann Arbor, offered some
observations and suggestions about the proposed changes to the Common
Rule, based on her experiences with regulatory and compliance oversight
at the University of Michigan. She described the university’s human
research protections program as one that seeks to maximize its opportuni-
ties to be flexible and innovative, and noted ways the university works to
take full advantage of the flexibility in the regulations concerning human
subjects protection. The university limits the scope of the federalwide
assurance by applying it only to federally funded projects. “It’s really
important on a campus like ours with so many student projects,” she said.
“This allows us to do some local review if we want. . . . Again, our school
has tried to take full advantage of this,” she noted.
The university also regulates only research that meets the defini-
73

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74 PROPOSED REVISIONS TO THE COMMON RULE
tion of human research. In 2012, 172 of the 1,024 new submissions to the
university’s health sciences and behavioral sciences institutional review
board (IRB-HSBS) were classified as not regulated.1 “We don’t want to
over-regulate,” she said. A large percentage of the protocols submitted
to the IRB-HSBS—more than 40 percent in 2011 and 2012—are exemptions
by IRB staff reviewers. Exemptions do not have to be granted by the IRB
itself, she noted; the process can be carried out by educated staff members.
The IRB-HSBS is also constantly using and streamlining its expedited
review process; in 2012 nearly 40 percent of the new submissions were
given expedited review. She added that the IRB-HSBS regularly uses
waivers or alteration of informed consent and waivers of documenta-
tion of informed consent, particularly for the social sciences, and it has
established cooperative research arrangements to avoid duplicate review.
As a result, even though the IRB-HSBS has about 1,200 projects
ongoing, the workload of the full committee has been reduced, and the
time it takes the committee to make decisions has been significantly
decreased, Brako said. For example, the median turnaround time for an
exempt determination went from five to six days in the first part of 2011
to one or two days by the end of 2012.2 The median turnaround time for
expedited approvals also has dropped, she said, and was at about 14 to
15 days in the second half of 2012.3
The university’s IRB-HSBS has also conducted demonstration projects
­
on minimal risk research. The projects cannot be federally funded or regu-
lated by the Food and Drug Administration, and they must not hold cer-
tificates of confidentiality. One demonstration allows two-year approvals,
and another created a new exemption category for secondary data anal-
ysis with identifiers. “In the first two years of our projects,” Brako said,
“we saved ourselves about 1,000 project reviews. . . . We also audited, and
we found no problems.”
Comments on ANPRM Proposals
Brako offered several comments about the proposed changes to the
Common Rule. The advance notice of proposed rulemaking (ANPRM),
she noted, proposed to create a category of “excluded” research that would
require only a one-page application and no review before research began;
there would be a data security check and a random audit later (Emanuel
and Menikoff, 2011). This is similar, Brako said, to a current University
1For details, see http://www.hrpp.umich.edu/Indicators_Report_January_2013_Final.pdf
[March 2013].
2Ibid.
3Ibid.

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PURVIEW AND ROLES OF INSTITUTIONAL REVIEW BOARDS 75
of Michigan IRB-HSBS process with a short application reviewed by an
IRB staff specialist. “So we’re already in a very streamlined mode, with a
one- to two-day turnaround time.”
Brako suggested that “registered” might be a better term than
“excluded” because “as an institution we’re responsible for connecting
up to federally funded projects. We really want to see these projects regis-
tered.” She also supported the idea of allowing investigators to determine
their own exemption status using standardized tools such as decisions
trees or exemption wizards. She said there is some advantage to main-
taining institutional screening processes to validate these exemptions but
believes it would be preferable to validate them before the initiation of the
research. Finally, she said, IRBs should continue to review ethical concerns
related to the protection of privacy and confidentiality, but they should
be able to rely on institutional resources, such as information technology
experts, for the evaluation of data security.
Brako said she sees great advantage to expanding the exemption
categories, and she made several suggestions for new exemption catego-
ries. These included social networking, the human testing of technology,
the analysis of secondary data with identifiers, minimal risk deception
research, the collection of data from videos and other recordings, and
group characteristics from surveys and interview.
In Brako’s view, new categories should be created for expedited review.
An expert panel composed of social scientists and other researchers, IRB
members and chairs, IRB administrators, and nonscientific IRB members
should be formed to determine what the new categories should be, she
added, and the panel should update the list regularly. The list from the
Council on Governmental Relations comments on the ANPRM, which
suggested new expedited categories for studies of Internet behavior,
functional magnetic resonance imaging at standard exposure levels, the
establishment of registries for future research purposes, and occupational
health activities, such as walking, deep breathing, and mild exercise,
could provide a starting point for this work, she noted.4 Brako also sug-
gested letting IRBs use expedited procedures for any other activities they
determine to be of minimal risk.
On the subject of the elimination of continuing review (Emanuel
and Menikoff, 2011), she said she strongly supports this for qualifying
minimal risk studies, but she added that the change should be accompa-
nied by clear guidance and examples of what IRBs would no longer be
required to do.
On the issue of a single IRB for multisite research, Brako said that she
4The list is available at http://www.regulations.gov/#!documentDetail;D=HHS-
OPHS-2011-0005-0656 [March 2013].

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76 PROPOSED REVISIONS TO THE COMMON RULE
supports a movement to reduce duplicate reviews by multiple IRBs, but
that it should not be mandated for all cases. There are reasons to have the
flexibility to use more than one IRB, she said.
Brako said she generally agrees with the idea of clarifying and harmo-
nizing regulatory requirements and agency guidance across the agencies.
Inconsistencies in guidance from various agencies—she mentioned the
Food and Drug Administration, Department of Defense, Department of
Justice, Department of Education, Environmental Protection Agency, and
the National Science Foundation in particular—weaken human subjects
protection by distracting researchers and IRBs from more important con-
siderations. They impede research by slowing the review process and by
confusing and intimidating researchers. However, she cautioned against
harmonizing by creating a “one-size-fits-all” approach to different types
of research, which often results in unfavorable cost–benefit ratios. Instead,
she would like to see a single, multiagency regulatory standard that cali-
brates its provisions to the nature and magnitude of risk that it addresses.
Brako offered comments on the proposed changes to informed con-
sent. “I think just about anyone would agree, that the process of informed
consent could be improved,” she said. Specifically, consent documents can
be greatly simplified if they focus on descriptions of the research activities,
the risks imposed by the experimental component, the potential benefits
of the research, and the burdens (e.g., financial, time commitments, altera-
tions in medical care) imposed by participation in the project. Mainly, she
said, what is needed for the social and behavioral sciences is flexibility.
Proposed Changes That Would Increase Burden
Some of the proposed changes in the ANPRM are likely to increase
the burden for institutions, and Brako identified several that would likely
prove particularly burdensome at the University of Michigan. Requiring
federal oversight of all human subjects research at an institution that
receives federal funding would be overly burdensome, she said. This
change would cause her institution to lose a lot of the flexibility that it has
taken advantage of in dealing with human subjects protection. Similarly,
mandating institutional data security and information protections when-
ever data are collected, generated, stored, or used would also be burden-
some. “I think there are many ways that we can deal with this data issue
in a different way,” Brako said.
Expanding the meaning of “human subject” to include biospecimens
without identifiers within the ANPRM provisions related to informed
risk and requiring written consent for the research use of de-identified
specimens would also increase the burden, Brako added. The proposal
to require records of adverse events and unanticipated problems to be

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PURVIEW AND ROLES OF INSTITUTIONAL REVIEW BOARDS 77
submitted and stored in a central database is premature, she said. There
is much to learn and understand before such a requirement is instituted,
in her view.
In summary, Brako said that while she supports several proposed
changes in the ANPRM that clearly reduce burden, she also believes
that in some cases clear and concise guidance could accomplish more
than changing the regulations in terms of assisting investigators, institu-
tions, and IRBs to better protect research participants. She said that she is
particularly concerned that some of the proposed changes seem to shift,
rather than reduce, the burden.
EFFECTS OF PROPOSED CHANGES ON
SOCIOCULTURAL ANTHROPOLOGY
Rena Lederman, of Princeton University, discussed how the pro-
posed changes to the Common Rule—and, in particular, the creation of
an “excused” category of research that has only informational risks—
would be likely to affect anthropologists and other ethnographers.
Lederman described the distinctive features of participant observa-
tion, which she described as “my discipline’s way of understanding
human experience.” This approach to research is quite different from
the approach in other areas of science, she explained, which makes it a
poor fit for the Common Rule in many ways.
To carry out their fieldwork, Lederman explained, anthropologists
immerse themselves in the lives of the people they study, communicating
in their language and staying for long stretches of time. The settings are
not controlled and thus not particularly suitable for systematic hypoth-
esis testing. “Our goal,” she said, “has generally been to put ourselves
in social situations controlled by the people whose circumstances we’re
interested in understanding, who are not therefore our subjects, but more
accurately our hosts, our interlocutors, our instructors, our consultants,
and increasingly our collaborators.” Unlike researchers in most of the
social and behavioral sciences, who do not form close relationships with
their subjects, ethnographers form relatively “thick” relationships with
their research participants. She explained that the researchers are being
observed by the participants at the same time that the participants are
observing them. These full and complex interactions with research partici-
pants are a major source of the understanding that ethnographers derive
from their research.
At the same time, these investigator–participant interactions do
not lend themselves to the sort of informed consent envisioned by the
Common Rule, Lederman said. A consent agreement works like a con-
tract, she said, spelling out the relationship between investigator and

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78 PROPOSED REVISIONS TO THE COMMON RULE
participant “in terms of a socially thin set of expectations and agree-
ments.” Such an agreement is not attuned to the relationship-thick ethical
demands of ethnographical fieldwork, she observed.
Problems with Proposed Data Privacy Protections
One of the key changes proposed in the ANPRM would be to allow
projects that pose only “informational” risks to be excused from under-
going prior IRB reviews of their research plans, as long as special data
privacy protections are instituted before the data analysis is begun,
Lederman noted. The ANPRM also proposes to classify the risks posed by
most anthropological research as informational. Consequently, Lederman
said, it might appear that the new “excused” category would be a boon
for anthropologists. Because the new rules place most anthropological
research in the informational risk category, she explained, anthropolo-
gists would no longer have to submit study designs to IRBs. However, in
her view, the current Common Rule’s demand for scientifically rigorous
project designs—which, by the nature of ethnographical work, are essen-
tially impossible to specify—undermines the training of students. This
provision “encourages the rest of us to offer misleadingly formalized
accounts of our prospective work,” Lederman said.
However, she continued, the special data privacy protections envi-
sioned by the ANPRM, based on the Health Insurance Portability and
Accountability Act privacy standards, would be equally ill-suited for eth-
nographical fieldwork. Although anthropologists do traditionally shield
the identities of their research participants through the use of pseud-
onyms, useful ethnographic descriptions require a significant amount of
contextual specificity. “De-identifying or anonymizing ethnographic data
would render them unusable,” she said.
Furthermore, she added, while data anonymization may be feasible
for such relationship-thin research as surveys and experiments, it is theo-
retically impossible for fieldwork if genuine anonymization means that
the investigators themselves are unable to re-identify research partici-
pants. The value of ethnographical research lies in the details amassed by
researchers in their long-term interactions with the research participants.
By the very nature of the work, researchers know the identities of the
participants, she explained. Thus de-identifying data before beginning
post-fieldwork analysis, as proposed in the ANPRM, would be unwork-
able for sociocultural anthropologists and other ethnographers.
The effective ethical oversight of sociocultural anthropology, ethno-
graphic sociology, and many other areas of the social and behavioral sci-
ences requires an approach that is not so narrowly grounded in the ethical
issues that arise in the biomedical sciences. One useful start, she observed,

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PURVIEW AND ROLES OF INSTITUTIONAL REVIEW BOARDS 79
would be to tighten up the definition of what is being regulated so as
to refocus IRB review more explicitly on biomedical and physical risk.
Doing so would enable IRBs to give potentially higher-risk projects the
attention they deserve, she suggested. Then alternative approaches could
be developed to more adequately address the actual ethical dilemmas of
sociocultural anthropology fieldwork and related forms of scholarship:
approaches that promote rather than undermine these sciences.
Lederman suggested forming a national commission to develop a
rationale and framework for promoting ethical conduct in those areas of
scholarship poorly served by or newly excused from the Common Rule.
Such a commission might be made up of experts in fields inadequately
served by the existing system of oversight, together with legal scholars
and philosophers knowledgeable about those fields. To avoid reinventing
the wheel, she explained, the commission should be instructed to draw
together and build on existing knowledge.
HUMAN SUBJECTS PROTECTION IN RESEARCH
FUNDED BY THE DEPARTMENT OF JUSTICE
Cheryl Crawford Watson, of the National Institute of Justice, described
human subjects protection in research funded by the Department of Jus-
tice (DOJ). Because of the sensitive nature of much of that research, which
often focuses on criminals and illegal activities, research is subject to
additional regulations protecting confidentiality, above and beyond the
Common Rule. This creates additional issues for the IRBs reviewing the
research, Watson observed.
Any research funded by the DOJ, Watson explained, is governed by
a confidentiality statute that not only forbids the release of identifiable
information by federal employees and those receiving federal funds, but
that also states that such information is immune from legal processes
and shall not, without the consent of the person who provided the evi-
dence, be used in any judicial, legislative, or administrative proceedings.
Researchers who receive funding from the DOJ who collect personally
identifiable information must submit a privacy certificate that describes
the research, promises that the researcher will comply with the confiden-
tiality requirements, and describes in detail the procedures the research
will use for protecting the confidentiality of the identifiably information
collected as part of that research. The procedures for protecting the confi-
dentiality of the information address, for example, the administrative and
physical security that will be used to protect the data, who will be allowed
access to the data, the information transfer agreements that will be used,
and details about the final disposition of the data, including how and in
what form it will be archived.

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80 PROPOSED REVISIONS TO THE COMMON RULE
The privacy certificate also includes details about what the research
participants will be told during informed consent discussions. Watson
added. They must be told that the information they provide will be used
only for research and statistical purposes, that the study is voluntary and
they can quit at any time, what the study’s risks and benefits are, how
the data will be securely maintained, and how the data will be archived
or disposed of after the study.
Confidentiality can only be broken with the subject’s consent, and
the identifiable data collected for the study can only be used for research
purposes with the subject’s consent. “We are a law enforcement agency,”
Watson explained. “Few would participate in DOJ-funded research
without strong protections on that identifiable data.” The one exception
is that the regulations do not apply to information collected regarding
future criminal intentions.
This exception can bring a researcher into conflict with state manda-
tory disclosure laws, she noted. Whereas the certificate of confidentiality
required by many other federal agencies allows a researcher to disclose
matters, such as child abuse, reportable communicable diseases, or a
subject threatening to harm someone, the privacy certificate required by
DOJ does not, she noted. Thus, when mandatory disclosure laws are an
issue, the researcher must get two different consent forms signed by the
participants—a consent to participate and a consent to allow reporting.
IRB Interactions with the DOJ
Because of these DOJ-specific regulations, researchers go through a
somewhat different process with DOJ than they would if their research
were funded by, for example, the Department of Health and Human
Services, Watson explained. IRBs play the same role with DOJ-funded
research as they do with research funded by other federal agencies. Extra-
mural research—that is, research funded by DOJ but performed outside
the department—is reviewed by the grantee’s own IRB or by a com-
mercial IRB. Intramural research is reviewed by the Office of Justice Pro-
grams’ IRB at DOJ.
DOJ research is governed by several federal laws and regulations,
including 42 USG § 3789g, which provides for confidentiality of informa-
tion. DOJ adopted the Common Rule but not its subparts, Watson noted.
However, if an IRB or a grantee organization has promised or, in its fed-
eralwide assurance has said, that it would follow the subparts, the DOJ
requests that it do so.
Researchers who receive DOJ funding need to understand that there
are withholding conditions on those funds, Watson said. For the funds
to be released, the DOJ must receive both the privacy certificate and the

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PURVIEW AND ROLES OF INSTITUTIONAL REVIEW BOARDS 81
Human Subjects Protection Form, which provides the grantee’s Federal-
wide Assurance number and IRB number and indicates whether the IRB
review has already taken place or whether it will take place at some point
in the future.
One of the main areas that cause concern is attempts by principal
investigators to self-exempt, she said. In some cases, the research truly
should be exempt; but in other cases, the research is greater than minimal
risk and the researcher has, for unknown reasons, decided that it fits
within the exemption criteria.
Another common issue is that IRBs are unaware of DOJ regulations,
particularly the confidentiality statute. Watson said she sees many consent
forms that specify that the investigator will report child abuse, suicidal
ideation, threat of harm to others, and so on. The DOJ will not accept such
forms. In other cases, the IRBs are simply confused by the regulations, she
added, as they are somewhat different from what IRBs usually encounter.
In at least two cases, researchers have decided not to take DOJ funding—
in one case after it had already been awarded—because the DOJ will not
accept informed consent forms that include mandatory disclosure state-
ments. To address these issues, the DOJ has an effort under way to com-
pile an information packet it will send to IRBs and principal investigators.
REFERENCE
Emanuel, E.J., and J. Menikoff. (2011). Reforming the regulations governing research with
human subjects. New England Journal of Medicine 365:1145–1150.

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